No | Primary DI | Version or Model | Catalog Number | Device Description | Product Code | Product Code Name | Device Class | Brand Name |
---|---|---|---|---|---|---|---|---|
1 | 00885556051375 | 71930717 | 71930717 | SYNERGY PC FEM SZ18 130MM | LPH | PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED | 2 | SYNERGY |
2 | 00885556799789 | 71075113B | 71075113B | SMART TSF FULL RING 130MM BLUE | KTT | APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, MULTIPLE COMPONENT | 2 | SMART TSF |
3 | 00885556765357 | E0016663-6 | E0016663-6 | HANDLE | HRY | PROSTHESIS, KNEE, FEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER | 2 | Legion |
4 | 00885556076538 | 913374 | 913374 | STAPLE 1.16X3.8X3.4 | JDR | STAPLE, FIXATION, BONE | 2 | NA |
5 | 00885556885208 | E0017815-2 | E0017815-2 | SHORTENED 180 2/3 RING | JDW | PIN, FIXATION, THREADED | 2 | Ex-Fix |
6 | 00885556883051 | E0017793-1 | E0017793-1 | MODIFIED META NAIL DROP | HSB | ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES | 2 | Meta Nail |
7 | 00885556867969 | E0017558-7 | E0017558-7 | FLEXIBLE I/M ROD | HRY | PROSTHESIS, KNEE, FEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER | 2 | Journey II |
8 | 00885556816721 | E0017448-3 | E0017448-3 | MODIFIED HEX DRIVER | HWR | DRIVER, PROSTHESIS | 1 | Polar |
9 | 00885556810484 | E0017443-1 | E0017443-1 | JII TIBIAL BLOCK - LEFT | FZX | Guide, surgical, instrument | 1 | JII |
10 | 00885556806326 | E0017367-11 | E0017367-11 | MODIFIED R3 INSERTER | JDI | Prosthesis, hip, semi-constrained, metal/polymer, cemented | 2 | R3 |
11 | 00885556805770 | E0017337-1 | E0017337-1 | JII FLEXION SPACER BLOCK | LXH | ORTHOPEDIC MANUAL SURGICAL INSTRUMENT | 1 | JII |
12 | 00885556804827 | E0017314-9 | E0017314-9 | AP BLOCK SZ 8 | FZX | Guide, surgical, instrument | 1 | Legion |
13 | 00885556802410 | E0017267-1 | E0017267-1 | TIBIAL STEM TRIAL - 10MM X 70MM | JWH | PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER | 2 | Legion |
14 | 00885556801673 | E0017241-1 | E0017241-1 | MIS DA X-BAR | JDG | Prosthesis, hip, femoral component, cemented, metal | 2 | R3 |
15 | 00885556800812 | E0017230-1 | E0017230-1 | 2MM RECUT BLOCK | HWT | TEMPLATE | 1 | Journey II |
16 | 00885556795255 | E0017150-1 | E0017150-1 | 11MM DEEP FLUTED END CUTTING REAMER | HTO | REAMER | 1 | Trigen |
17 | 00885556793893 | E0017119-7 | E0017119-7 | MIS ACETABULAR REAMER 58MM | HTO | REAMER | 1 | R3 |
18 | 00885556791905 | E0017091-2 | E0017091-2 | TIBIAL CUTTING BLOCK - RT | HRY | PROSTHESIS, KNEE, FEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER | 2 | Legion |
19 | 00885556790229 | E0017054-1 | E0017054-1 | MODULAR FIN PUNCH HANDLE | HRY | PROSTHESIS, KNEE, FEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER | 2 | JII |
20 | 00885556783313 | E0016980-3 | E0016980-3 | UPPER TIBIAL GUIDE | HRY | PROSTHESIS, KNEE, FEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER | 2 | Journey II |
21 | 00885556777954 | E0016892-1 | E0016892-1 | 9MM REAMER HEAD | HTO | REAMER | 1 | Trigen |
22 | 00885556775103 | E0016853-3 | E0016853-3 | EXTENDED T8 DRIVER SHAFT | HXX | SCREWDRIVER | 1 | PERI-LOC |
23 | 00885556773673 | ROB20000 | ROB20000 | CORI ROBOTICS USA | OLO | Orthopedic stereotaxic instrument | 2 | Real Intelligence |
24 | 00885556771013 | E0016765-1 | E0016765-1 | MODIFIED ANGEL WING | HRY | PROSTHESIS, KNEE, FEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER | 2 | Legion |
25 | 00885556770566 | E0016753-1 | E0016753-1 | FLUTED CURVED CANNULATED AWL | HWJ | AWL | 1 | Trigen |
26 | 00885556763742 | 71170734 | 71170734 | EVOS LARGE PROXIMAL HUMERUS PLATE TRAY | FSM | TRAY, SURGICAL, INSTRUMENT | 1 | EVOS |
27 | 00885556763155 | E0016528-7 | E0016528-7 | SZ 51MM BRIDGEBACK REAMER | HTO | REAMER | 1 | R3 |
28 | 00885556762189 | 72581004 | 72581004 | EVOS 3.5MM/4.5MM UTILITY PLATE 4H 147MM | HRS | Plate, fixation, bone | 2 | EVOS |
29 | 00885556757192 | E0016586-2 | E0016586-2 | 8.5MM REAMER HEAD | HWE | INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT | 1 | Trigen |
30 | 00885556757116 | E0016583-1 | E0016583-1 | RAT TAIL RASP | JDG | Prosthesis, hip, femoral component, cemented, metal | 2 | Polar |
31 | 00885556755068 | ROB10000 | ROB10000 | CORI Starter Kit | OLO | Orthopedic stereotaxic instrument | 2 | CORI |
32 | 00885556753682 | E0016536-2 | E0016536-2 | ZUK SPACER BLOCK - 11MM | HWT | TEMPLATE | 1 | Uni |
33 | 00885556752081 | 72546585N | 72546585N | EVOS 6.5MM X 85MM CANNULATED SCREW | HWC | Screw, fixation, bone | 2 | EVOS |
34 | 00885556740422 | E0016327-2 | E0016327-2 | IM ROD SHORT | HRY | PROSTHESIS, KNEE, FEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER | 2 | JII |
35 | 00885556737392 | E0016303-3 | E0016303-3 | OFFSET FIXATION ROD | HRY | PROSTHESIS, KNEE, FEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER | 2 | JII |
36 | 00885556733837 | E0016253-2 | E0016253-2 | LARGE BLADE | GAD | RETRACTOR | 1 | Anthology |
37 | 00885556725337 | E0016116-2 | E0016116-2 | 2MM RECUT BLOCK | HWT | TEMPLATE | 1 | Legion |
38 | 00885556722701 | 21-8020 | 21-8020 | DEPTH GAGE | LXH | ORTHOPEDIC MANUAL SURGICAL INSTRUMENT | 1 | N/A |
39 | 00885556627020 | PFSI00040 | PFSI00040 | Stride Poly Insert Size D 9mm | HSX | PROSTHESIS, KNEE, FEMOROTIBIAL, NON-CONSTRAINED, CEMENTED, METAL/POLYMER | 2 | STRIDE |
40 | 00885556716274 | E0015966-1 | E0015966-1 | FEMORAL STYLUS | HRY | PROSTHESIS, KNEE, FEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER | 2 | Legion |
41 | 00885556715536 | E0015722-1 | E0015722-1 | FEMORAL TRIAL PADDLE | HRY | PROSTHESIS, KNEE, FEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER | 2 | Legion |
42 | 00885556626979 | PFSI00033 | PFSI00033 | Stride Poly Insert Size C 8mm | HSX | PROSTHESIS, KNEE, FEMOROTIBIAL, NON-CONSTRAINED, CEMENTED, METAL/POLYMER | 2 | STRIDE |
43 | 00885556713662 | 72411812 | 72411812 | EVOS 1.8MM X 12MM LOCKING PEG T7 | HRS | Plate, fixation, bone | 2 | EVOS |
44 | 00885556710357 | E0015809-1 | E0015809-1 | SIDE FEMORAL HEAD IMPACTOR | LXH | ORTHOPEDIC MANUAL SURGICAL INSTRUMENT | 1 | R3 |
45 | 00885556710418 | E0015860-1 | E0015860-1 | IM ALIGNMENT GUIDE WITH THUMB SCREWS | HRY | PROSTHESIS, KNEE, FEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER | 2 | Legion |
46 | 00885556710241 | E0015781-3 | E0015781-3 | SPIKED ELEVATOR - STRAIGHT | HTE | ELEVATOR | 1 | Peri-loc |
47 | 00885556708675 | E0015708-5 | E0015708-5 | GII PS TRIAL INSERT 5-6 9MM | JWH | PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER | 2 | Legion |
48 | 00885556706978 | E0015771-1 | E0015771-1 | 2MM RECUT BLOCK | HWT | TEMPLATE | 1 | Legion |
49 | 00885556704561 | E0015694-2 | E0015694-2 | PATELLA DEPTH GAUGE - 5MM | HRY | PROSTHESIS, KNEE, FEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER | 2 | Legion |
50 | 00885556704455 | E0015672-1 | E0015672-1 | JOURNEY CR FEMORAL IMPACTOR | JWH | PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER | 2 | Journey II |
No | Primary DI | Version or Model | Catalog Number | Device Description | Brand Name | Organization Name |
---|---|---|---|---|---|---|
1 | 10840199507563 | 7225-25 | 7225-25 | Dandy Nerve Hook Right 20cm | Nerve Hook | KOROS U.S.A., INC. |
2 | 10840199507556 | 7225-20 | 7225-20 | Dandy Nerve Hook Left 20cm | Nerve Hook | KOROS U.S.A., INC. |
3 | 10840199507549 | 7225-15 | 7225-15 | Dandy Nerve Hook Straight 20cm | Nerve Hook | KOROS U.S.A., INC. |
4 | 10840199507532 | 7225-10 | 7225-10 | Hoen Nerve Hook Angled 22cm | Nerve Hook | KOROS U.S.A., INC. |
5 | 10840199507525 | 7225-05 | 7225-05 | Hoen Nerve Hook Straight 22cmhttps://gudid.fda.gov/gudid/app/admin/udi/recordDet Hoen Nerve Hook Straight 22cmhttps://gudid.fda.gov/gudid/app/admin/udi/recordDetails.xhtml# | Nerve Hook | KOROS U.S.A., INC. |
6 | 10705034773667 | 388.63 | 38863 | HOOK POSITIONER | NA | SYNTHES GMBH |
7 | 10705034773186 | 388.485 | 388485 | PELVIC HOOK FOR EXTENDED THORACIC DISTRACTOR | NA | SYNTHES GMBH |
8 | 10705034773179 | 388.484 | 388484 | RIB HOOK FOR EXTENDED THORACIC DISTRACTOR | NA | SYNTHES GMBH |
9 | 10705034500706 | 698343457 | 698343457 | MODIFIED INSTRUMENT BALL TIP FEELER RIGHT 7mm | NA | DEPUY SPINE, LLC |
10 | 10705034500652 | 698343456 | 698343456 | MODIFIED INSTRUMENT BALL TIP FEELER LEFT 7mm | NA | DEPUY SPINE, LLC |
11 | 10705034500515 | 698343455 | 698343455 | MODIFIED INSTRUMENT BALL TIP FEELER STRAIGHT 7mm | NA | DEPUY SPINE, LLC |
12 | 10705034500379 | 698343421 | 698343421 | MODIFIED INSTRUMENT BALL TIP FEELER, RIGHT 10mm | N/A | DEPUY SPINE, LLC |
13 | 10705034500362 | 698343420 | 698343420 | MODIFIED INSTRUMENT BALL TIP FEELER, LEFT 10mm | N/A | DEPUY SPINE, LLC |
14 | 10705034500355 | 698343419 | 698343419 | MODIFIED INSTRUMENT BALL TIP FEELER, STRAIGHT 10mm | N/A | DEPUY SPINE, LLC |
15 | 10705034492315 | 698341946 | 698341946 | MODIFIED INSTRUMENT NERVE HOOK, STANDARD | NA | DEPUY SPINE, LLC |
16 | 10705034486482 | 698342204 | 698342204 | MODIFIED INSTRUMENT Ball Tip Hook 10mm | NA | DEPUY SPINE, LLC |
17 | 10705034486475 | 698342205 | 698342205 | MODIFIED INSTRUMENT Ball Tip Hook 5mm | NA | DEPUY SPINE, LLC |
18 | 10705034460437 | 698339874 | 698339874 | MODIFIED INSTRUMENT BALL TIP FEELER, LEFT, 11mm | NA | DEPUY SPINE, LLC |
19 | 10705034225852 | 292906005 | 292906005 | SPOTLIGHT ACCESS SYSTEM BALL TIP NERVE HOOK 5mm | SPOTLIGHT | DEPUY SPINE, LLC |
20 | 10705034225845 | 292906004 | 292906004 | SPOTLIGHT ACCESS SYSTEM MICRO TIP NERVE HOOK, RIGHT | SPOTLIGHT | DEPUY SPINE, LLC |
21 | 10705034225838 | 292906003 | 292906003 | SPOTLIGHT ACCESS SYSTEM MICRO TIP NERVE HOOK, LEFT | SPOTLIGHT | DEPUY SPINE, LLC |
22 | 10705034225821 | 292906002 | 292906002 | SPOTLIGHT ACCESS SYSTEM MICRO TIP NERVE HOOK, REVERSE | SPOTLIGHT | DEPUY SPINE, LLC |
23 | 10705034225814 | 292906001 | 292906001 | SPOTLIGHT ACCESS SYSTEM MICRO TIP NERVE HOOK, FORWARD | SPOTLIGHT | DEPUY SPINE, LLC |
24 | 10653160327141 | I68785 | I68785 | ST IUD REMOVAL HOOK 10' (504090) | Centurion | CENTURION MEDICAL PRODUCTS CORPORATION |
25 | 10653160317227 | I68655 | I68655 | STERILE LILLIE EAR HOOK DELICATE 7' | Centurion | CENTURION MEDICAL PRODUCTS CORPORATION |
26 | 10653160313564 | I68660 | I68660 | STERILE VON STRABISMUS HOOK 5.5 | Centurion | CENTURION MEDICAL PRODUCTS CORPORATION |
27 | 10653160294627 | I68540 | I68540 | ST SKIN HOOK 1 PRONG BLUNT 6 1/2'(25762) | Centurion | CENTURION MEDICAL PRODUCTS CORPORATION |
28 | 10649111453144 | 47-2502C | CENSITRAC READY JOSEPH HOOK 2PRG SH 2MM 6.25 IN | Sklar | SKLAR CORPORATION | |
29 | 10649111439391 | 40-6858C | CENSITRAC READY BONE HOOK SMALL 9 INCHES 10MM | Sklar | SKLAR CORPORATION | |
30 | 10649111399237 | 50-1310 | CUSHING NERVE HOOK #2 11" | Sklar® | SKLAR CORPORATION | |
31 | 10649111395413 | 50-1790C | CENSITRAC READY DANDY NERVE HOOK STRAIGHT | Sklar | SKLAR CORPORATION | |
32 | 10649111395239 | 47-2760C | CENSITRAC READY FREER SKIN HK 2PR SHP 2.5MM 6 IN | Sklar | SKLAR CORPORATION | |
33 | 10649111395208 | 47-2651C | CENSITRAC READY GUTHRIE DBL HOOK SHRP SM | Sklar® | SKLAR CORPORATION | |
34 | 10649111395192 | 47-2572C | CENSITRAC READY GILLIES SKIN HOOK 7" 4MM | Sklar® | SKLAR CORPORATION | |
35 | 10649111395185 | 47-2570C | CENSITRAC READY GILLIES SKIN HOOK 7" 3MM | Sklar® | SKLAR CORPORATION | |
36 | 10649111395178 | 47-2555C | FRAZIER TISSUE HOOK SH 5" | Sklar® | SKLAR CORPORATION | |
37 | 10649111395154 | 47-2510C | CENSITRAC READY JOSEPH HOOK 2/PR SH 6 1/4 10MM | Sklar® | SKLAR CORPORATION | |
38 | 10649111395147 | 47-2507C | CENSITRAC READY JOSEPH HOOK 2/PR SH 6 1/4" 7MM | Sklar® | SKLAR CORPORATION | |
39 | 10649111395086 | 47-2462C | CENSITRAC READY MEYERDING SKIN HOOK D/E 6 1/4" | Sklar® | SKLAR CORPORATION | |
40 | 10649111394430 | 40-6857C | CENSITRAC READY BONE HOOK MEDIUM 9" 8MM X 25MM | Sklar® | SKLAR CORPORATION | |
41 | 10649111385612 | 47-2505C | CENSITRAC READY JOSEPH HOOK 2PRG SH 5MM 6.25" | Sklar® | SKLAR CORPORATION | |
42 | 10649111385605 | 47-2500C | CENSITRAC READY JOSEPH HOOK 1PRG SH 6.25" | Sklar® | SKLAR CORPORATION | |
43 | 10649111375347 | 47-2061 | FISCH DELICATE HOOK 7.5" | Sklar® | SKLAR CORPORATION | |
44 | 10649111347153 | 06-4175 | RAMELET HOOK SET/2 FINE/MED LF | Sklar® | SKLAR CORPORATION | |
45 | 10649111346613 | 06-4172 | RAMELET HOOK SET/2 FINE/MED RT | Sklar® | SKLAR CORPORATION | |
46 | 10649111346019 | 40-8364 | SACHS NERVE ROOT HOOK 7 1/4" | Sklar® | SKLAR CORPORATION | |
47 | 10649111338830 | 97-0543 | JOHNSON TUCKER HOOK &FORK 6.5" | Sklar® | SKLAR CORPORATION | |
48 | 10649111302503 | 93-8007 | KREY HOOK 8" DBL ACTION | Sklar® | SKLAR CORPORATION | |
49 | 10649111302282 | 93-8006 | OSTERTAGS EYE HOOK BLUNT 2" | Sklar® | SKLAR CORPORATION | |
50 | 10649111265341 | 95-821 | GUTHRIE DBL HOOK 2LG SH PRG | Sklar® | SKLAR CORPORATION |